FDA's warnings on Paxil gain momentum

FDA's warnings on Paxil gain momentum

The Food and Drug Administration advised pregnant women to stay away from the antidepressant Paxil because it could raise the risks of birth defects.

However, the agency was understated in its warning saying that it “is advising patients that this drug should usually not be taken during pregnancy.”

The advice came after two studies revealed adverse health conditions in the children of mothers who had taken Paxil during the first three months of pregnancy. It found that they were 1 1/2 to two times more prone to giving birth to children with defects in their hearts than women who had other antidepressants or none at all.

Robert Temple, the FDA's director of medical policy, said: “If you're on Paxil and pregnant, our advice is to talk to your physician and consider switching to a different drug. Abrupt withdrawal of Paxil has its own problems, but the clear suggestion here is that you might want to think about a change.”

Now it is being debated if pregnant women, who are susceptible to depression, should take anti-depressants or not. The Journal of the American Medical Association published a study which found that the babies born to mothers, who had taken antidepressants during pregnancy, were thrice more likely to suffer from peevishness, tremors and convulsions soon after their birth.

According to Gaile Renegar, Glaxo spokeswoman, the company was addressing the issue by studying as to how and why Paxil could have been the cause of these defects.

Kimberly Yonkers, a psychiatrist at the Yale School said that the findings used by the FDA studies might have had limitations. She said: “Depression is still undertreated. Pregnant women in particular are immensely undertreated, and you worry about people being unduly frightened.”

Paxil is one of most used antidepressants in the world after its approval in 1993. in generic form as Paxil is marketed as paroxetine.